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Recently, the 38th meeting of the Standing Committee of the Sixth People's Congress of Hainan Province deliberated and adopted the Several Provisions on Drug Import Facilitation in Hainan Free Trade Port
.
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First, it is clarified that enterprises importing drugs from the designated Hainan Free Trade Port drug import port shall file with the drug administration department where the port is located in accordance with the law, and do not need to apply for the "Customs Clearance Form for Imported Drugs"
.
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Second, after receiving the application materials for the filing of imported drugs, the drug administration department where the port is located finds that the materials submitted by the importing pharmaceutical enterprise meet the filing requirements after review, it shall complete the relevant formalities for import filing on the same day, exchange the electronic information for filing to the customs, and inform the importing pharmaceutical enterprise of the filing result
.
Imported pharmaceutical enterprises that are approved for filing shall go through customs declaration and release formalities
with the Customs in accordance with law.
.
Imported pharmaceutical enterprises that are approved for filing shall go through customs declaration and release formalities
with the Customs in accordance with law.
Third, it stipulates that the drug regulatory department at the location of the port shall, according to the needs of the importing drug enterprises, provide the enterprises with customs clearance certificates
for imported drugs free of charge.
for imported drugs free of charge.
Fourth, the drug regulatory departments shall strengthen the supervision and management of the circulation and use of imported drugs, conduct spot checks and inspections in accordance with law, establish enterprise credit archives for imported drugs, increase the frequency of supervision and inspection of imported drug enterprises with bad credit records, and implement joint punishments
with relevant departments in accordance with law.
with relevant departments in accordance with law.
Fifth, emphasizing the main responsibility of enterprises, enterprises importing drugs should establish and implement management systems such as information traceability of imported drugs and pharmacovigilance, comply with the requirements of quality management practices for drug sales, and ensure the quality safety and traceability
of imported drugs.
of imported drugs.
